We can hardly believe this. The FDA announced there are additional blood pressure pills recalled. Yup, you guessed it! The FDA is expanding the valsartan recall…again! We have lost count of how many times the Food and Drug Administration has had to revise its list of companies that are in trouble because of contaminated valsartan. In addition, there’s a recall for the most prescribed blood pressure pill in the world: hydrochlorothiazide (HCTZ). It is a diuretic. According to our calculations, over 20 million Americans swallow it daily.
HCTZ Blood Pressure Pills Recalled?
Let’s start with the new recall. It’s a crisis! A pharmacy discovered that its 100-count bottles of hydrochlorothizide (abbreviated HCT or HCTZ) contained a different diuretic by mistake. The manufacturer was Accord Healthcare. Instead of 12.5 mg of HCTZ, the bottles contained 25 mg of spironolactone. Trust us when we tell you that this is a potentially life-threatening mistake (more details below).
Here is the FDA’s August 27, 2018, release:
“Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.
“A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.
“Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals. To date, Accord has not received any reports of adverse events related to this recall.”
“Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.
“Accord’s Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.”
Why Is this Such A Big Deal?
Hydrochlorothiazide depletes the body of potassium. It’s usually not that big a deal, but it needs to be monitored. Physicians may prescribe it with a blood pressure drug that preserves potassium. That way there is a delicate balance between the two so that potassium levels stay in the sweet spot. An example might be an ACE inhibitor like lisinopril. It helps the body retain potassium. There are even combination pills that contain both lisinopril and HCTZ.
The trouble is that spironolactone, also a diuretic, preserves potassium. If you were to combine lisinopril (which also preserves potassium) together with spironolactone you could end up with excessive potassium buildup (hyperkalemia). Too much potassium can lead to irregular heart rhythms or sudden cardiac death. People with kidney problems are especially vulnerable to hyperkalemia, but even healthy people can succumb.
How Would You Know Whether Your HCTZ Is Recalled?
First, look to see if you are taking 12.5 mg tablets. That should be on the label. Get out your magnifying glass and see if you can find the name of the manufacturer, Accord Healthcare, Inc. While you are at it, check to see if the pharmacy put a lot number on your bottle of pills. To our dismay we have discovered that many pharmacies do not do this. The lot number of the Accord Healthcare recall is PW05264. If you are unsure, CALL your pharmacy and ask who the manufacturer of your hydrochlorothiazide is and what lot number the pharmacy used to fill your prescription.
Where Did the Mixup Occur?
We went searching for Accord Healthcare. What we found was a glowing mission statement:
“Our mission is to join the hospitals, pharmacists, wholesalers, and other front-line healthcare providers in the vital delivery of life-sustaining drugs to their patients.
“By placing orders with the highest levels of precision, taking personal and mutual responsibility for support needs, and considering the patient’s well-being as our primary goal, we continue to foster Accord Healthcare’s enduring reputation for quality and integrity.
“As we support front-line healthcare providers through accurate delivery of high-quality pharmaceuticals, our focus is on the patients who require our medications for relief from illness and the restoration of health. Our success is measured by the trust we cultivate in the medical community who increasingly look to us as a dependable resource.”
This sounds impressive, but we would have to conclude that Accord Healthcare had quality control problems based on their mislabeling of spironolactone. We also discovered that Accord Healthcare is
“an emerging large-scale provider of generic pharmaceuticals in the United States. Our U.S. headquarters is in Durham, North Carolina, near the Research Triangle Park (RTP).”
The Head Office Address:
Nr. Sola Bridge, S.F. Highway,
Ahmedabad – 380 054, India
We have no idea where the mislabeling occurred.
The Valsartan Scandal Continues!
HCTZ are not the only blood pressure pills recalled this week. We can hardly believe it, but the FDA has once again expanded the list of companies that have sold contaminated valsartan. To read about the history of this debacle, go to this link.
“Torrent Pharmaceuticals Limited is expanding its voluntary recall. FDA has updated the list of valsartan products under recall.”
“Torrent Pharmaceuticals Limited is expanding its voluntary recall to all lots of unexpired valsartan-containing drug products due to the detection of NDMA in the active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.
“RemedyRepack, a repackager of Torrent’s valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets, has also recalled.”
You can find a list of the valsartan products under FDA recall at this link:
The People’s Pharmacy Perspective:
Enough! We are sick and tired of these mistakes. We hope you noted that it was not the FDA that discovered the disastrous mistake with hydrochlorothiazide. It was a pharmacist! A vigilant guardian of our health caught a potentially lethal error. Next time you fill your prescription, please take a moment to thank the pharmacist for taking time to check for quality and for drug interactions.
And please let your legislators know that you would like country of origin information placed on every medicine that is dispensed in the U.S. If you know where your shoes and shirts come from, why not your pills?
Share your own thoughts below in the comment section.